A large clinical trial might be said to resemble an ocean liner, which is leaving Southampton to sail to New York. It is a complicated system. There will be a captain on the bridge and a large crew. They will have filed a course some time before they set sail, but not everything can be foreseen in advance; the weather for example. Sometimes small corrections to the route will need to be made en voyage. These will be meticulously recorded, authorised by the ship’s owners, otherwise known as the Trial Steering Committee, which can overrule the captain if needed. Occasionally something happens; the vessel is seaworthy, the cabins are ready, and the band has started playing, but the ship never sets out, most often because they can’t get enough passengers on board to make the voyage worthwhile. Very occasionally there is a shipwreck, but this is very rare. Few trials suffer the fate of the Titanic, but sometimes the ship gets to the USA, but not to New York, but some other place; destination changed en route, which is considered bad form. In that case, people may debate for years afterwards what actually pushed them off course, and what that means. But most often the ship does eventually dock in New York, with satisfied passengers, and a tired but relieved crew.

One oresponse (below the bluster) hits the argument below the waterline.

Graham McPhee

NEW CANARD PASSENGER LINE

Southampton to New York in 5 days

Canard has announced the successful first voyage of its flagship, the Queen Mary Pace. Built in Oxford to rigorous specifications, this sleek and sophisticated liner, with the latest engines built with Graduated Energy Transmission, has taken the world by storm with the first crossing in just 5 days.

Setting out from Southampton on 18th March, 2005, amid cheers from admiring crowds in the medical enclosure, it left harbour looking every inch the awesome and standard-setting giant that it is.

With everyone settled in and enjoying the cruise, the captain called together his senior crew and decided to make some minor adjustments to the course plotted. Informing the management back at Canard, these quickly took place, and a mere 5 days later, passengers found themselves at the quayside in Dublin.

“All changes were rigorously discussed with the senior crew,” explained the captain. “It was felt important to make changes that truly reflected the potential of the new engine arrangement. Dublin is an entirely normal destiny for cruise liners.”

A number of passengers complained, but, as management at Canard explained, “There are always vexatious passengers on any cruise. All decisions were taken in their interests, and, naturally, it would be inappropriate for passengers unfamiliar with the ways of the sea to be allowed to comment on such matters. The crew had unusually tranquil seas and clement weather to contend with: it is too easy to criticize from the sidelines.” The UK government, which invested heavily in this engineering miracle, recommends that everyone should experience this very effective service.

When questioned, 22% of the passengers said that they thought Dublin was much better or even very much better than they had realized: but another analysis showed that, actually, none of them ever ended up in New York, even two years later.

"Behavioural research should not have a “get out of jail free” card when it comes to scientific rigour"

Lancet reviewers should take note of this statement as the gatekeepers of scientific rigour. The cost of the research (£5m) should also be questioned when considering allegations of defrauding the taxpayers.

"It's time to stop saying that this is a just figment of people's imagination. This is a real disease, with real physical manifestations that need to be identified and cared for," Committee Chair Ellen Wright Clayton, MD, JD, professor of pediatrics and director of the Center for Biomedical Ethics and Society at Vanderbilt University, Nashville, Tennessee.

Wessely will no longer want PACE cruises going to America or beyond the British Isles as psychological theory collapses.

That "there were a significant number of patients who did not improve with these treatments. Some patients deteriorated, but this seems to be the nature of the illness, rather than related to a particular treatment". And must be further limping weighed down by the acknowledgement that no bed bound patients were included.

This seems to be the nature of the illness! If I didn't laugh I would howl,

I am willing not to chuck the baby out with the bath water but really!

"But according to the theory underlying this psychiatric research, my problem was that I was out of shape, afraid of exercise, and obsessed about my symptoms. The path to wellness was to drop the idea that I had a physical disease and steadily increase my exercise, no matter how bad it made me feel.

Patients rapidly discovered serious scientific problems with the 2011 Lancet paper. Despite these errors, the study, known as the PACE trial, went on to inform recommendations from such influential bodies as the Centers for Disease Control and Prevention, the Mayo Clinic, and the British National Health Service. So the new follow-up study, I feared, seemed destined for a warm and uncritical reception from the medical establishment regardless of whether its findings were legitimate"

The authors of the PACE trial were possibly aware that a warm uncritical reception had no historical context, although the firestorm from beyond the usual suspects, can scarcely have entered their worst nightmares.